Body fluid testing device

• US 7,731,900 B2
• Filed: 05/06/2005
• Issued: 06/08/2010
• Est. Priority Date: 11/26/2002
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Hoenes, Joachim, Haar, Hans-Peter, Zimmer, Volker, Miltner, Karl, Manser, Maria, List, Hans, Pachl, Rudolf
• Primary Examiner(s): Nagpaul; Jyoti
• Application Number:
  US11/124,591
• Publication Number:
  US 20050201897A1
• Time in Patent Office: 1,859 Days
• Field of Search: 600583-584, 422 55- 57, 422 63- 68, 422 99-100, 436/92, 436/110, 436/901
• US Class Current: 422/66
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/0006 involving a colour change
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 33/48764 Test tape taken off a spool
• CPC Class Codes: G01N 35/00009 provided with a sample supporting tape, e.g. with absorbent zones
• CPC Class Codes: G01N 35/1016 Control of the volume dispensed or introduced
• CPC Class Codes: Y10S 436/901 Drugs of abuse, e.g. narcotics, amphetamine
• CPC Class Codes: Y10T 436/141111 Diverse hetero atoms in same or different rings [e.g., alkaloids, opiates, etc.]
• CPC Class Codes: Y10T 436/173076 Nitrite or nitrate

Abstract

The present invention concerns a body fluid testing device (10) for analyzing a body fluids, comprising a test media tape (30) adapted to collect the body fluid, a supply portion (100) storing an uncontaminated section of the test media tape, a storage portion (110) for storing a contaminated section of the test media tape, an exposure portion positioned between the supply portion and the storage portion, the exposure portion being adapted to expose a section of the test media tape to the body fluid. An important aspect is a tip portion (20) for exposing a test medium to body fluid application. The application further concerns a test media cassette for housing test media. Another aspect is a testing device and method that employs illumination of a test medium at the site for body fluid application.

Claims

1. A body fluid testing device for analyzing a body fluid, comprising:

a test media tape adapted to collect the body fluid,

a supply portion storing an uncontaminated section of the test media tape,

a storage portion for storing a contaminated section of the test media tape,

an exposure portion positioned between the supply portion and the storage portion, the exposure portion being adapted to expose a section of the test media tape to body fluid on a body surface,

wherein said exposure portion has a tip portion for exposing a test medium of said test media tape to body fluid application and said tip portion imposing a change of direction to said tape which is above 60°

, and the body fluid testing device further comprising optics coupled with the tip portion;

said body fluid testing device having a housing with an outer contour;

wherein said tip portion at least partially extends outside the outer contour of said housing;

wherein said tip portion has an illumination channel and a detection channel;

a proximal end of said illumination channel has a light source to illuminate said test medium;

wherein said test medium is located above a distal end of said illumination channel; and

wherein light reflected from said test medium enters said detection channel and is received by a detector.

2. The device of claim 1, wherein said tip portion is located at a distal end of the device.

3. The device of claim 1, wherein said test media tape is housed in a cassette.

4. The device of claim 1, wherein said tip portion comprises guiding means which guide the test media tape to avoid a slip of the tape off the tip portion.

5. The device of claim 4, wherein said guiding means are one or more guide rails or at least one channel.

6. The device of claim 1, wherein said tip portion includes at least one optical channel for illuminating a test medium and/or detecting light reflected by a test medium.

7. The device of claim 1, wherein:

the supply portion includes a supply reel, wherein the uncontaminated section of the test media tape is wound on the supply reel; and

the storage portion includes a storage reel, wherein the contaminated section of the test media tape can be wound on the storage reel.

8. The device of claim 1, further comprising a piercing device adapted to pierce skin.

9. The device of claim 8, wherein said piercing device is arranged to pierce a body portion located at the tip portion.

10. The device of claim 1 further comprising a sensor for sensing a change of a test medium induced by reaction with said body fluid.

11. The device of claim 10, wherein the sensor includes:

a light source and a detector;

a light transmission means coupled to the light source, the transmission means being adapted to transmit light from the light source onto a test medium; and

a light detection means the detection means being adapted to receive reflected light from said test medium and transmits the reflected light to the detector for analysis.

12. The device of claim 1, wherein said tip portion is part of the device.

13. The device of claim 1, wherein said tip portion is adapted to impose a change of direction to said tape which is above 60 degrees while said tape is external to said housing.

14. A test cassette for housing test media for sampling body fluid, comprising:

a section for receiving test media tape that is contaminated with past samples of the body fluid and an uncontaminated section;

a housing including a supply portion in which the uncontaminated section of the test media tape is enclosed, the housing further including a storage portion in which a contaminated section of the test media tape can be enclosed, the housing defining an exposure opening at which the test media tape is exposed to the body fluid;

wherein the test cassette further comprises a tip portion which guides the test media tape to expose a portion for body fluid application;

wherein said tip portion extends at least partially outside said housing to guide the test media tape to a position external to said housing;

wherein said tip portion has an illumination channel and a detection channel;

a proximal end of said illumination channel has a light source to illuminate said test medium;

wherein said test medium is located above a distal end of said illumination channel; and

wherein light reflected from said test medium enters said detection channel and is received by a detector.

15. The test cassette of claim 14, wherein said housing has a recess for receiving a sensor belonging to a testing device.

16. The test cassette of claim 14, wherein said cassette has a channel which forms the sole air connection between the storage portion and the surroundings of the cassette.

17. The cassette of claim 16, wherein successive test media on the test media tape have a distance, said distance being chosen that when a first test medium is located on the tip portion the successive test element is located within the storage portion being sheltered from humidity by said channel.

18. The cassette of claim 14, wherein successive test media on the test media tape have a distance, said distance being chosen that when a first test medium is located on the tip portion the successive test element is located within the housing of the test cassette.

19. The cassette of claim 18, wherein said distance is chosen so that when a first test element is located on the tip portion the successive test element is covered by overlying tape.

20. A body fluid testing device for analyzing a body fluid, comprising:

a test media tape adapted to collect the body fluid,

a supply portion for storing an uncontaminated section of the test media tape,

a storage portion for storing a contaminated section of the test media tape,

an exposure portion positioned between the supply portion and the storage portion, the exposure portion being adapted to expose a section of the test media tape to the body fluid;

said testing device further comprising a light source for illuminating an area of the test media tape located within said exposure portion to guide a user for body fluid application;

said body fluid testing device further comprising a housing with an outer contour and a tip portion over which said test media tape runs at said exposure portion;

wherein said tip portion at least partially extends outside said outer contour of said housing;

wherein said tip portion has an illumination channel and a detection channel;

a proximal end of said illumination channel has a light source to illuminate said test medium;

wherein said test medium is located above a distal end of said illumination channel; and

wherein light reflected from said test medium enters said detection channel and is received by a detector.

21. The testing device of claim 20, wherein said light source is a light source for illuminating the test media tape for analysis of body fluid.

22. The testing device of claim 20, wherein said illuminated area is the area to which body fluid has to be applied.

23. The testing device of claim 20, further having a control unit controlling activation of said light source, said control unit activating said light source when the testing device desires a body fluid sample to be applied to the test media tape.

24. The testing device of claim 20, wherein said light source illuminates an area which corresponds to a volume of body fluid required for proper analysis.

25. A system for analyzing a body fluid, comprising:

a body fluid testing device having a housing with an outer contour;

a test media tape adapted to collect the body fluid;

a supply portion storing an uncontaminated section of the test media tape inside the housing;

a storage portion for storing a contaminated section of the test media tape inside the housing;

a convex tip portion over which the test media tape runs between the supply portion and the storage portion;

the convex tip portion at least partially projecting outside the outer contour of the housing to expose a section of the test media tape to the body fluid outside the housing of the body fluid testing device;

wherein said convex tip portion has an illumination channel and a detection channel;

a proximal end of said illumination channel has a light source to illuminate said test medium;

wherein said test medium is located above a distal end of said illumination channel; and

wherein light reflected from said test medium enters said detection channel and is received by a detector.

26. The system of claim 25, further comprising a sensor to analyze the fluid collected on the test media tape.

27. The system of claim 25, wherein the test media tape has successive test media spaced apart a distance where a first test medium is located on the convex tip portion and a second test medium is located within the housing.

28. The system of claim 25, further comprising:

the convex tip portion including an illumination channel and a detection channel;

a light source aligned with the illumination channel to illuminate at least part of the section of the test media tape located outside of the housing; and

a detector aligned with the detection channel to receive the light from the light source that is reflected from the test media tape.

29. The system of claim 28, wherein the light source is configured to illuminate an area of the test media tape that corresponds to an area to be wetted by the body fluid to allow proper analysis by the detector.

30. The system of claim 28, wherein the body fluid testing device comprises a control unit for controlling activation of the light source when the body fluid testing device requires the body fluid for analysis.

31. The system of claim 25, wherein the test media tape has light guiding properties and the body fluid testing device guides light into the test media tape so that a portion of the test media tape onto which the body fluid is applied is illuminated.